title: Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.
abstract: BACKGROUND
  Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina.
  
  
  METHODS
  Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting.
  
  
  CONCLUSIONS
  Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations.
  
  
  BACKGROUND
  NCT01809431.
authors.affiliation: School of Nursing, The University of North Carolina at Chapel Hill, Campus Box 7460, Chapel Hill 27599-7460, NC, USA. dberry@email.unc.edu.
authors.forename: Diane C
authors.initials: DC
authors.lastname: Berry
authors.forename: Madeline
authors.initials: M
authors.lastname: Neal
authors.forename: Emily G
authors.initials: EG
authors.lastname: Hall
authors.forename: Todd A
authors.initials: TA
authors.lastname: Schwartz
authors.forename: Sarah
authors.initials: S
authors.lastname: Verbiest
authors.forename: Karen
authors.initials: K
authors.lastname: Bonuck
authors.forename: William
authors.initials: W
authors.lastname: Goodnight
authors.forename: Seth
authors.initials: S
authors.lastname: Brody
authors.forename: Karen F
authors.initials: KF
authors.lastname: Dorman
authors.forename: Mary K
authors.initials: MK
authors.lastname: Menard
authors.forename: Alison M
authors.initials: AM
authors.lastname: Stuebe
mesh_terms: D050154:Adiposity; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D001942:Breast Feeding; D002657:Child Development; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000517:prevention & control; D016640:Diabetes, Gestational; D004032:Diet; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D006801:Humans; D007223:Infant; D009043:Motor Activity; D009657:North Carolina; D010353:Patient Education as Topic; D011181:Postnatal Care; D011236:Prediabetic State / Q000097:blood / Q000517:prevention & control; D011247:Pregnancy; D012107:Research Design; D020377:Self Efficacy; D060145:Text Messaging; D014280:Triglycerides / Q000097:blood; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D014280:Triglycerides